Stability Data Specialist - GMP/QA Regulatory Focus (Hybrid)

Eurofins USA PSS Insourcing Solutions; Lexington (MA); Hybrid; USD 43,000 - 48,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

Life and disability insurance

401(k) with company match

Paid vacation and holidays

Bonus potential

Job summary

Eurofins USA PSS Insourcing Solutions in Lexington, MA is hiring for a hybrid, non-laboratory role supporting Quality and Analytical functions. You will collaborate with internal teams and external partners to ensure data integrity, regulatory compliance, and timely deliverables.

The role requires a Bachelor's in Chemistry or related field, 2+ years in GMP environments, and strong documentation skills. Occasional travel to Cambridge is expected.

Qualifications

• Bachelor's degree in Chemistry, Biology, or a related field.
• 2+ years of relevant industry experience.
• Experience in Quality Control, Quality Assurance, or GMP-regulated environment.
• Experience in Analytical Development preferred.
• Familiarity with analytical methods for biologics or small molecule products is a plus.
• Strong GMP principles and regulatory compliance.
• Strong communication and documentation skills.
• Authorized to work in the U.S. permanently without sponsorship.

Responsibilities

• Collaborate with departmental colleagues to complete assignments under supervision.
• Review and interpret analytical data with client support; contribute to technical reports and regulatory documentation.
• Evaluate QC testing data for small molecule and/or biologics methods from external vendor laboratories.
• Enter GMP data into validated database systems accurately and efficiently.
• Verify data and trending tables for inclusion in regulatory submissions.
• Build and manage stability studies within validated systems, as applicable.
• Ensure GMP data aligns with current specifications; generate Certificates of Analysis (COAs) when required.
• Monitor and trend reference standards and analytical data.
• Identify and escalation routine technical issues or vendor-related concerns.
• Troubleshoot basic issues using available resources and guidance.
• Travel between Lexington and Cambridge client sites as needed.

Skills

Quality Control

Regulatory compliance

Communication

Time management

Team collaboration

Education

Bachelor's degree in Chemistry, Biology, or a related field

Tools

Validated database systems

COA generation workflow software

Job description

Eurofins USA PSS Insourcing Solutions in Lexington, MA is hiring for a hybrid, non-laboratory role supporting Quality and Analytical functions. You will collaborate with internal teams and external partners to ensure data integrity, regulatory compliance, and timely deliverables.

The role requires a Bachelor's in Chemistry or related field, 2+ years in GMP environments, and strong documentation skills. Occasional travel to Cambridge is expected.